Govt issued draft notification to amend Rule 43 of MD Rules 2017

It also said that the objections and suggestions which may be received from any person within the period will be considered by the Central Government

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Govt of India Gazette of India
Gazette of India

Download the notification No. GSR No. 23(E) dt 18-01-2022: As part of its efforts to implement improved regulations on medical devices in the country, the Union Ministry of Health and Family Welfare (MoHFW) has notified a draft rule incorporating provisions for suspension and cancelation of import license in the Medical Devices Rules, 2017 vide notification No. GSR No. 23(E) dt 18-01-2022.

Download the notification No. GSR No. 23(E) dt 18-01-2022.

The draft rule, amending the Medical Devices Rules, proposes to insert a rule after the Rule 43, which is related to import of medical devices for personal use, namely Rule 43 A under which the suspension and cancelation of license will be brought into the Rule.

The draft says that if the manufacturer or licensee fails to comply with any of the conditions of an import license, or any provisions of the Act and those rules, the Central Licensing Authority (CLA) may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reason, cancel the license issued under the rules or suspend it for such a period as it thinks fit either wholly or in respect of any of the part of medical device to which it relates.

Under the Rule, the Authority could also direct the licensee to stop import, sale or distribution of the said medical device and order the destruction of medical device and stock in presence of officer authorised by the CLA, if in its opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or rules.

However, it also added a provision under which the person aggrieved by the order passed by the CLA under the rule, may file an appeal to the Central Government within 30 days of the serving of the order. The Central Government may, after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for hearing, pass such order as it thinks fit, it added.

The draft notification has been published for the information of all persons likely to be affected. It has also issued a notice that the said draft rule shall be taken into consideration or after the expiry of a period of fourth-five days from the date on which the copies of the Gazette of India these draft rules are made available to the public.

It also said that the objections and suggestions which may be received from any person within the period will be considered by the Central Government. The new rule is named as Medical Devices (…Amendment) Rules, 2021.

The MoHFW has been bringing in rules and amendments into the medical devices sector, both in terms of imported products and in terms of India devices, including classification of all medical devices into four classes based on their risk level. Following this, these medical devices will be brought under license regime in a fixed timeframe based on the classification.

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